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Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

NCT ID: NCT04867369

Last Updated: 2024-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2023-11-11

Brief Summary

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A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.

Detailed Description

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Conditions

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Tendonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pecs II block

80 patients scheduled for open biceps tenodesis

Group Type EXPERIMENTAL

Bupivacaine 20mL 0.5%

Intervention Type DRUG

Interscalene nerve block with 20 mL 0.5% bupivacaine.

Bupivacaine 20mL 0.25%

Intervention Type DRUG

Pecs II fascial plane block with 20 mL 0.25% bupivacaine.

Surgical infiltration

80 patients scheduled for open biceps tenodesis

Group Type ACTIVE_COMPARATOR

Bupivacaine 20mL 0.5%

Intervention Type DRUG

Interscalene nerve block with 20 mL 0.5% bupivacaine.

Bupivacaine up to 15mL 0.25%

Intervention Type DRUG

Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.

Interventions

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Bupivacaine 20mL 0.5%

Interscalene nerve block with 20 mL 0.5% bupivacaine.

Intervention Type DRUG

Bupivacaine 20mL 0.25%

Pecs II fascial plane block with 20 mL 0.25% bupivacaine.

Intervention Type DRUG

Bupivacaine up to 15mL 0.25%

Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients between 18 and 75 years of age
2. Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis

Exclusion Criteria

1. Patients younger than 18 and older than 75;
2. Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
3. Patients who are allergic to oxycodone;
4. Patients with diagnosed or self-reported cognitive dysfunction;
5. Patients with a history of neurologic disorder that can interfere with pain sensation;
6. Patients with a history of drug or recorded alcohol abuse;
7. Patients who are unable to understand or follow instructions;
8. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
9. Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
10. Patients with a BMI over 45;
11. Any patient that the investigators feel cannot comply with all study related procedures;
12. NYU Langone Health students, residents, faculty or staff members.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur Hertling, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20-01978

Identifier Type: -

Identifier Source: org_study_id